Nutritional composition for bariatric surgery patients

ABSTRACT

A nutritional composition particularly suitable for use by morbidly obese patients pre and post bariatric surgery comprises 20-60 wt % protein source, 15-55 wt % carbohydrate, 10-20 wt % soluble dietary fibres, less than 10 wt % fat and micronutrients. The micronutrients comprise
         0.75-3 wt % calcium,   0.5-1.8 wt % phosphorus,   12.5-100 mg/100 g of iron,   10-100 mcg/100 g vitamin D, and   175-560 mcg/100 g vitamin B12
 
the wt % being based on the dry weight of the total composition.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT/EP2009/004469 FILED Jun. 19,2009, which claims the benefit of PCT/EP2008/004943 filed Jun. 19, 2008.

FIELD OF THE INVENTION

The invention relates to nutritional compositions particularly suitablefor use by morbidly obese patients pre and post bariatric surgery. Theproduct helps decrease liver size when used in patients following acalorie restricted diet in the period preceding bariatric surgery andfurther helps to maintain bone health and optimal nutritionalrequirements in the post bariatric surgery patients.

The composition comprises protein, digestible carbohydrate, dietaryfibers, specific micronutrients and preferably no or very low amounts offat.

BACKGROUND OF THE INVENTION

The rate of increase in obesity in the Western world is a major healthproblem affecting millions of people. Bariatric surgical proceduresincluding gastric bypass represent a successful way to achievesignificant weight reduction in morbidly obese individuals. Followingsurgery it is estimated that up to one-third of the patients suffernutritional deficiencies that cannot be corrected by normal diet alone.

From the literature, it is evident that nutritional deficiencies arecommon in both pre and post bariatric surgery patients. Thesedeficiencies are specific depending on the type of surgery performed andpost-operative deficiencies are further exacerbated. In the USA the mostcommon surgery is the Roux-en-Y gastric bypass (RYGBP) at 65.1%,followed by adjustable gastric band (AGB) at 24%, vertical bandedgastroplasty (VBG) at 5.4% and Bilio-pancreatic diversion (BPD) at 4.9%[1].

VBG and AGB are purely restrictive, resulting in a 30-50 ml gastricpouch. Normal absorption is still possible, but deficiencies occur as aresult of the greatly reduced overall volume of food intake. RYGBP ispredominantly restrictive but also results in some malabsorption. Thestomach pouch is decreased to 20-30 ml and the duodenum is completelybypassed in the surgery. In addition, a short segment of the jejunum mayalso be bypassed, resulting in mild fat and protein malabsorption. TheBPD is a primarily malabsorptive procedure with some restriction [2;3].

Large liver size impedes laparoscopic surgery in this patient group. Anintense pre-surgery weight loss programme (4-6 weeks) has been found tosignificantly reduce liver size. Currently available weight lossproducts are not designed to address specific micronutrient needs ofthis patient group without additional multivitamin supplementation asthey only contain micronutrients up to RDA levels. To meet RDAs formicronutrients, up to 5 servings of a protein containing weightmanagement formula may need to be consumed in addition to multivitaminstaken several times a day. The need to take several supplements each daycan lead to reduced compliance over time resulting in clinicaldeficiencies.

Protein malnutrition is a real risk in bariatric surgery patients. Manypatients require protein supplementation during the early phases ofrapid weight loss, to prevent excessive loss of muscle mass. Theadvantage of a protein containing, low calorie product specificallydesigned to meet or exceed micro-nutrient requirements, for use inpatients pre and post bariatric surgery, is that patients can learn tocombine healthy eating and product use without total reliance on mealreplacers even before the surgical procedure is performed.

SUMMARY OF THE INVENTION

The objective of the invention is therefore to prepare a balancednutritional product that addresses the specific nutritional needs ofgastric bypass patients. To this end, the present invention provides acomposition comprising 20-60 wt % protein source, 15-55 wt %carbohydrate, 10-20 wt % soluble dietary fibres, less than 10 wt % fatand micronutrients, wherein the micronutrients comprise

0.75-3 wt % calcium,

0.5-1.8 wt % phosphorus,

12.5-100 mg/100 g of iron,

10-100 mcg/100 g vitamin D, and

175-560 mcg/100 g vitamin B12

the wt % being based on the dry weight of the total composition.

The unit “mcg” represents micrograms.

Compositions according to the invention are specifically designed foruse in obese gastric bypass patients for inducing liver size reductionwhen used pre-operatively, prevention and/or treatment of bone calciumdepletion and osteopenia, prevention and treatment of post-operativenutritional deficiencies, improving GI function or bowel health,induction of weight loss pre and post surgery, inducing satiety,preventing dumping syndrome or for maintaining glycaemic control. Theproduct is therefore designed for both pre and post operative bariatricsurgery patients, to be taken as part of a prescribed diet plan

The composition according to the invention includes protein and aspecially designed blend of vitamins and minerals. The product will meetor exceed RDAs for all vitamins, trace elements, magnesium andphosphorus and will be low in calories and volume.

Preferred features of the invention are set out below as (i)-(vi).

-   -   (i) The protein source is a low lactose or lactose free protein        source (preferably whey based and even more preferably in        hydrolysed form) present in the composition in an amount of        20-60 g/100 g of the composition (i.e. 20-60 wt %), more        preferably 20-40 g/100 g of the composition (i.e. 20-40 wt %).    -   (ii) The carbohydrate (which is present in an amount of 15-55 wt        %) is preferably a low glycemic carbohydrate, e.g. selected from        fructose, galactose, isomaltulose and slow digestible starch.    -   (iii) The soluble dietary fibres, which are present in the        composition in an amount of 10-20 wt % are preferably inulin        and/or oligo fructose.    -   (iv) Fat present in the composition is a blend of hybrid        safflower oil, canola oil and coconut oil which provide an        optimal ratio of linoleic to α-linolenic acid.    -   (v) The iron (present in an amount of 12.5-100 g of composition)        is preferably fat coated.    -   (vi) The ratio of calcium to phosphorus (i.e. the Ca:P ratio) is        1.4.

A preferred composition in accordance with the invention comprises allof features (i)-(vi).

DETAILED DESCRIPTION OF THE INVENTION

The product according to the invention is intended to be used to supportliver size reduction when used pre-operatively, maintain nutritionalbiomarkers of bone health (PTH; parathyroid hormone) following surgery,(n.b. PTH concentrations are increased in post-operative gastric bypasspatients which over time can result in bone calcium depletion leading toosteopenia). The product addresses pre and post-operative nutritionaldeficiencies by aiding mineral absorption (via prebiotic inclusion),improvement of GI function/bowel health and supports weight loss pre andpost surgery due to the product contributing only 27% of total energyrequirements of a low calorie diet (recommended calorie intake around1200 kcal/day). The product has a satiety inducing effect, a lowglycemic index and avoids dumping syndrome.

The compositions according to the invention comprise 20-60 wt % proteinsource, 15-55 wt % low glycemic carbohydrate, 10-20 wt % soluble dietaryfibers, less than 10 wt % fat and micronutrients, wherein themicronutrients comprise per 100 dry weight product; Iron 12.5-100 mg,175-560 mcg vitamin B12, 0.75-3 g calcium, 10-100 mcg vitamin D, and0.5-1.8 g phosphorus preferably with a Ca:P ratio of 1.4, wherein the wt% is based on the dry weight of the total composition and “mcg” standsfor micrograms. The amount of phosphorus may be 0.5-1.5 wt %.Alternatively or additionally the amount of vitamin B12 may be 175-500mcg.

Protein Source:

The levels of protein are between 20-60 g per 100 g powder (i.e. 20-60wt %) and are intended to provide from 20-40 g protein in total per day,the remainder being provided from the diet. Daily requirements are 60-70g per day for bariatric patients. A low lactose or lactose free proteinsource is preferred due to the lactose intolerance experienced postsurgery.

In a preferred embodiment the protein is in the form of a hydrolysate.Protein hydrolysates (sources of peptides) are widely used in situationswhere there is difficulty digesting or absorbing whole protein withinthe gut. Small peptides are absorbed whole across the intestinal wallvia carrier mediated transport systems. Once absorbed, they arehydrolysed by peptidases. The resulting free amino acids then enter theportal circulation. Thus including a protein hydrolysate will offerpotential benefit in that the protein source will be easily and readilyabsorbed. Whole protein, preferably whey based as it is more easilydigested than casein, may however be used as part or whole of theprotein source if improved taste is required. Protein also has a mildsatiety inducing effect. Thus another potential benefit of includingsignificant amounts of protein in the composition is in its satietyinducing effects.

Carbohydrate & Fiber:

As the product according to the invention is designed to have lowcalorie density between 15-55 g carbohydrates is used per 100 g powderand is intended to provide a maximum of 55 g carbohydrates per day. Animportant consideration with GBP patients is the possibility of dumpingsyndrome which occurs when sugars move too quickly through the stomachand intestines. Dumping syndrome causes nausea, weakness, sweating,faintness and possibly diarrhoea soon after eating. It is preferred thatthe product has an overall low glycemic index to ensure a slow releaseof glucose into the blood stream.

Consuming a low GI product has a positive effect on overall glycemiccontrol in obese diabetic patients and in conjunction with weight losswill result in patients reducing or completely stopping their diabeticmedications. It is preferred that the overall glycemic index is medium(36-50), and ideally low GI (<36). Therefore, the compositions accordingto the invention are particularly suitable for improving the glycemiccontrol of obese diabetic patients pre and post bariatric surgery, whileat the same time weight loss associated nutritional deficiencies can beprevented or restored.

In another preferred embodiment the composition comprises low glycemicindex carbohydrates, i.e. carbohydrates that have a glycemic index (GI)below 50. Preferably these carbohydrates comprise Fructose (19),Galactose (23), Isomaltulose (33), and/or slow digestible starches, suchas maize starch. Alternatively the glycemic index of the composition canbe reduced by inhibiting the digestive enzyme alpha-amylase which isresponsible for the digestion of complex carbohydrates. Slowing thisdigestive process lowers the Glycemic Index (GI) of maltodextrin and/orstarch containing foods. The use of these low GI carbohydrates willresult in improved glycemic control pre and post bariatric surgery.

One key benefit of dietary fibers is their ability to increase mineralabsorption, particularly calcium. The inventors found that this benefitis especially desirable in obese individuals who are more at risk ofsuffering osteoarthritis, osteoporosis and weak bones in later life andin patients following GBP surgery who may be at risk of bonedemineralization due to vitamin D and calcium deficiencies.

Powdered compositions in accordance with the invention may be diluted toprovide a drink or a mousse. One of the proposed benefits of the productfor patients following gastric bypass surgery is inclusion ofnon-nutritive ingredients that induce feelings of satiety and thusprevent a patient consuming a larger portion of food than required. Anumber of possible ingredients have been reported to have potentialbenefit in this area such as guar gum, pectin or mucilages by delayinggastric emptying through their gel-forming effects. A traditionalthickening ingredient such as these would not be ideal however for asmall volume product such as this and the inventors found that the useof soluble dietary fibres such as prebiotics are considered to representthe most promising option. Preferably the volume is as small aspossible, but at least less than 150 ml since such small volume isoptimally acceptable by the post surgery patient.

Dietary fibers as used in this invention are typically resistant todigestion and absorption in the human small intestine with preferably acomplete or partial fermentation in the large intestine. Preferably thepresent composition comprises at least one dietary fibre capable ofstimulating the growth of bifodobacteria in the gut selected from thegroup consisting of galactooligosaccharides including transgalactooligosaccharides, inulin, fructooligosaccharides,xylooligosaccharides, palatinoseoligosaccharide, resistant starch,lactulose, lactosucrose, mannanoligosaccharides,isomaltooligosaccharides, maltooligosaccharides, glucomannan,arabinogalactan, soybean oligosaccharide, gentiooligosaccharide, pectin,pectate, chondroitine, hyaluronic acids, heparine, heparane, bacterialcarbohydrates, sialoglycans, fucooligosaccharides, xanthan gum,polydextrose (PDX), galactomannans, preferably guar gum, arabinoxylan,preferably MGN-3 Rice Bran Arabinoxylan according to U.S. Pat. No.5,560,914, xyloglycan, callose, and/or degradation products thereof. Allof these have beneficial prebiotic and bifidogenic effects in theintestinal system. PDX is a non-digestible carbohydrate that has beensynthesized from randomly cross-linked glucose and sorbitol.

The inventors found that a combination of fructooligosaccharides andinulin result in longer-lasting feelings of satiety as these ingredientsare fermented throughout the colon. These dietary fibres have greaterrelevance longer term as a patient adapts and becomes able to ingestlarger quantities of food which may lead to unwanted weight gain.

In addition to a role in satiety induction it is well reported thatdietary fibres are important for development of good colonic microflorawith stimulation of gastrointestinal health via increasing the body'snatural resistance to invading pathogens. Therefore a preferred use ofthe compositions according to the present invention, comprising dietaryfibres, are particularly useful in stimulating the natural resistance toinvading pathogens in obese bariatric surgery patients.

Increased blood cholesterol is a major problem in obese bariatricsurgery patients. Part of the dietary treatment of these patients isrelated to the lowering of the blood cholesterol levels. A primarybenefit of including dietary fibre is its effect on lowering bloodcholesterol levels which has been demonstrated by several studies [4;5].

A preferred embodiment according to the invention comprises the Orafti™Synergy 1 prebiotic which is an oligofructose enriched inulin, thiscontains a combination of short and long chain oligosaccharides.Combinations of the two fractions are physiologically more efficaciousthan the individual components. Whilst there has been no Tolerable UpperIntake Level (UL) set for dietary fibre intakes, distress (e.g.diarrhoea, flatulence, bloating and cramping) may be expected withintakes above 15-18 g/day of inulin. Therefore in the patient group forwhich this product is designed, who have undergone bariatric surgery andwill have limited daily intakes it is preferred to incorporate levels ofbetween 5-25 g/day of the Orafti™ Synergy 1. These levels will bewell-tolerated by this patient group as has been reported in previousstudies in patients with lower GI conditions such as ulcerative colitisor colon cancer.

Fat:

There is no requirement in this patient group to include an additionalfat source. Fats are discouraged in this group as they can significantlyincrease the calorie content of the diet. Thus inclusion of fats willalso increase the calorie content of the proposed supplement. The aim isto produce a supplement that is very low in calories with levels thatare between 0 and 10 g/100 g, preferably between 0 and 5 g/100 g powder.Fat is sometimes required to optimise taste and acceptability of theproduct. If a fat source is used, a preferred blend comprises hybridsafflower oil, canola oil and coconut oil. Such blend will provide asufficient amount of α-linolenic acid (ALA) which is subsequentlyconverted by the liver into eicosapentanoic acid (EPA). Preferably anoptimal ratio of linoleic (LA) to α-linolenic acid (ALA) is providedwherein the level of LA provided is 1.8 g/day, preferably between 1.3and 2.7 g day. Preferably the level of ALA provided is 0.45 g/day,preferably between 0.27-0.67 g day. These would preferably be includedin a ratio of LA:ALA of 4:1 to 10:1.

Alternatively a fat blend can be used comprising eicosapentanoic acid(EPA) wherein at least 0.1 gram EPA is provided per 100 g dry weight,preferably providing between 0.1 and 0.5 g EPA per 100 g dry weight.

Micronutrients:

The composition contains levels of the micronutrients iron, calcium,phosphorus, vitamin D, E and B₁₂ to meet specific requirements ofpatients following bariatric surgery. The rationale for these isdescribed in detail below. The remainder of the vitamins, trace elementsand magnesium will be provided at levels that will meet US RDAs up to150%, as it is suggested that all patients take a prenatal multivitaminsupplement (containing increased iron and other micronutrients) as aprophylactic measure regardless of whether they have identifieddeficiencies or not. The levels of the electrolytes sodium, potassiumand chloride will be at levels inherent in the ingredients used.

Iron:

Iron deficiency appears to be quite common following bariatric surgery.Incidences of deficiency ranging from 14-52% have been reported. Inorder to be absorbed, dietary non-haem iron requires gastric acid toreduce the ferric ion to the ferrous state. As a result of bariatricsurgery, the amount of gastric acid is greatly reduced thereby limitingabsorption of iron from food. Iron is also absorbed in the duodenum(which is totally bypassed) and proximal jejunum (some of which isbypassed in the surgery). In menstruating women this deficiency isfurther exacerbated. The composition in accordance with the inventioncomprises 12.5-100 mg per 100 g dry weight product or iron, preferablybetween 12.5 and 75 mg/100 g, intended to provide a daily dose of from12.5-60 mg. In a preferred embodiment the proposed level of iron is justbelow the US upper limit of 45 mg per day. In another preferredembodiment fat coated iron will be used. This has the advantage that thetaste of the composition will be significantly improved.

Vitamin B12:

In normal, healthy individuals, gastric acid and peptic acid arerequired to release vitamin B12 from food. In the duodenum, the vitaminthen binds to intrinsic factor, which is then absorbed in the terminalileum. Post bariatric surgery, gastric acid is virtually absent as theacid secreting cells are mostly located in the fundus of the stomach,which is bypassed, making it difficult for patients to effectivelyrelease Vitamin B12 bound in food. Good sources of this vitamin areprimarily red meats and dairy products that may be excluded or limitedfrom the diets of this patient group due to intolerances, making it evenmore difficult to meet requirements. It has been described in literaturethat there is frequently a lack of symptoms which may lead to delayeddiagnosis of a condition which results in irreversible neurologicaldamage if deficiency is maintained for a long period of time.

The composition according to the invention comprises vitamin B12 in anamount of 175-560 mcg per 100 g (more preferably 175-500 mcg/100 g) tomatch the minimal level of 150 mcg daily. Since the patients haveproblems with vitamin B12 absorption it is preferred to go for higherlevels of this vitamin in order to maximise availability of the vitaminas total absorption increases with increasing intake. A preferredembodiment therefore comprises vitamin B12 in an amount of 250 to 500mcg/100 g product, even more preferably 275 to 500 mcg/100 g productresulting in a daily dose of at least 250 mcg.

Calcium, Vitamin D and Phosphorus:

Abnormal levels of calcium and vitamin D have been reported pre-surgery.It is postulated that this is possibly due to reduced exercise,decreased sunlight exposure and increased storage in body fat withresultant decreased bioavailability.

Calcium deficiency is predictable in this patient group as calcium infood is mostly absorbed in the duodenum and proximal jejunum, which isbypassed in RYGBP, via an inactive, saturable process mediated byVitamin D. Stomach acid is also required to convert calcium in food to asoluble form for absorption. Decreased intakes of dairy products due tointolerance, secondary to lactase deficiency or previously maskedintolerance will also lead to reduced calcium intakes post surgery. Theinventors found that all patients should be supplemented with levels atleast equal to or exceeding the RDA. A preferred embodiment thereforecomprises between 1200-1500 mg calcium as daily dose.

Preferred levels of calcium in the product according to the inventionwill be at least 1000 mg per 100 g (i.e. 1 wt %) providing at least 1000mg calcium per day. Even more preferably the composition containsbetween 1200-3000 mg calcium/100 g providing at least 1500 mg per day.Without being bound by theory the inventors expect that these higherlevels of calcium will allow optimal absorption of calcium in thispatient group. To increase bioavailability, calcium in the form of acitrate or gluconate will be used.

Several retrospective studies have shown a deficiency of vitamin Dfollowing gastric bypass surgery. Calcium can also be absorbed in thealkaline environment of the small intestine through a vitamin Ddependent mechanism. The range of vitamin D per 100 g is between 10-100mcg, preferably between 10-30 mcg (more preferably 10-20 mcg) giving adaily intake of at least 10 mcg. In a preferred embodiment vitamin D₃ isused since this form is more effective than D₂ at increasing levels ofvitamin D hormone in circulation. These higher levels help to optimisecalcium absorption.

The proposed levels of phosphorus will be from 500 to 1800 mg per 100 g(i.e. 0.5-1.8 wt %), more preferably 500 to 1500 mg per 100 g (i.e.0.5-1.5 wt %). These levels are well below the US upper limit of 4000mg. In order to maximise bone health it is prudent to maintain a Ca:Pratio of 1.4 as per RDAs.

Vitamin C and Vitamin E:

Preferred vitamin C levels are between 50-2000 mg per 100 g product. 90mg per day is the RDA for 19-50 year old males whose requirements areslightly higher than females. Any excess vitamin is readily excreted bythe body, and the upper limit for vitamin C is 2000 mg per day.

Preferred levels of vitamin E are between 20-1000 mg tocopherolequivalents per 100 g product. This will provide a total daily intake ofat least 40 mg. US RDAs are in the range of 15-19 mg per day and the USupper limit is 1000 mg per day. In the absence of definitive evidence ofvitamin E deficiencies post RYGBP, the aim is to provide levels that atleast meet recommended intakes and will also act to reduce oxidativestress as previously mentioned.

These increased levels of vitamin C & E are incorporated due toincreased iron intakes in this product. the aim is to provide levelsthat at least meet recommended intakes and will also act to reduceoxidative stress. Vitamin C is known to aid absorption of non-haemeiron. Cook and Monsen [9] found that the increase in iron absorption wasdirectly proportional to the amount of vitamin C added. The ICMRBulletin report (2000) recommends that in order to reduce oxidativestress in humans, daily administration of therapeutic doses of iron mustbe accompanied by supplementation with a combination of ascorbic acidand vitamin E.

Energy Density:

Total calories have been kept to a minimum. Each composition preferablycontains less than 500 kcal per 100 g, even more preferably between 200and 400 kcal per 100 g.

Packaging Powder Formulation

The composition of the invention may be supplied as a powder to apatient. The powder may then be reconstituted with water. Sufficientwater may be added to produce a low volume drink or less water may beadded to obtain a mousse-like consistency.

By way of example, the powder may be supplied as a (one dose) sachetcontaining about 45.3 g of powder. 80 ml of water may be used toreconstitute into a low volume drink. Less water (20-30 ml) can be addedto obtain a mousse like consistency. The powder may be designed so thatit can be made up either as a “pudding” or a “drink”.

Liquid Formulation

Alternatively the powder may be reconstituted by the manufacturer andsupplied to the patient as a “ready to drink” formula. Since bariatricsurgery patients have a small stomach volume, it is essential that thevolume is kept low. Preferably the volume of a single dose should notexceed 150 ml, more preferably no more than 100 ml and even morepreferably less than 50 ml. The inventors expect that if the volumewould exceed the maximum volume of 150 ml, the bariatric surgerypatients will not be able to comply with the product intake required forobtaining the claimed effects of the product.

Uses of the Compositions

The composition may be used to improve several symptoms in bariatricsurgery patients. Examples of the symptoms are obesity, osteopenia,dumping syndrome and nutritional deficiencies.

The compositions according to the invention can preferably be used in amethod for

a. inducing liver size reduction when used pre-operatively,b. prevention and treatment of post-operative nutritional deficienciesc. preventing dumping syndromed. induction of weight loss pre and post surgeryin obese gastric bypass patients, wherein the method comprises theadministration of a composition comprising 20-60 wt % protein source,15-55 wt % carbohydrate, 10-20 wt % soluble dietary fibres, less than 10wt % fat and micronutrients, wherein the micronutrients comprise Iron12.5-100 mg/100 g, 0.175-0.560 mcg vitamin B12, 0.75-3 wt % calcium,0.000010-0.000100 wt % (10-100 mcg/100 g) vitamin D, and 0.5-1.8 wt %phosphorus wherein the wt % is based on the dry weight of the totalcomposition. The amount of phosphorus may be 0.5-1.5 wt %. Alternativelyor additionally the amount of vitamin B12 may be 175-500 mcg.

Osteopenia refers to bone mineral density (BMD) that is lower thannormal peak BMD but not low enough to be classified as osteoporosis.Bone mineral density is a measurement of the level of minerals in thebones, which indicates how dense and strong they are. If your BMD is lowcompared to normal peak BMD, you are said to have osteopenia. Havingosteopenia means there is a greater risk that, as time passes, you maydevelop BMD that is very low compared to normal, known as osteoporosis.Patients that are obese and undergo bariatric surgery are at increasedrisk to develop Osteopenia and osteoporosis. The compositions accordingto the invention are particularly suitable to prevent and/or treatosteopenia and osteoporosis in these patients because they compriserelatively high amounts of calcium, phosphorus and vitamin D.

Dumping syndrome is most common in patients with certain types ofstomach surgery, such as a gastrectomy or gastric bypass surgery thatallow the stomach to empty rapidly. Gastric dumping syndrome, or rapidgastric emptying, happens when the lower end of the small intestine, thejejunum, fills too quickly with undigested food from the stomach.“Early” dumping begins during or right after a meal. Symptoms of earlydumping include nausea, vomiting, bloating, cramping, diarrhea,dizziness and fatigue. “Late” dumping happens 1 to 3 hours after eating.Symptoms of late dumping include weakness, sweating, and dizziness. Manypeople have both types. In addition, people with this syndrome oftensuffer from low blood sugar, or hypoglycemia, because the rapid“dumping” of food triggers the pancreas to release excessive amounts ofinsulin into the bloodstream. This type of hypoglycemia is referred toas “alimentary hypoglycemia”. The compositions according to theinvention are particularly suitable for the treatment and/or preventionof dumping syndrome since the high protein levels and fibers in theproduct will decrease the rate of gastric emptying and the low glycemiccarbohydrates will decrease the raise in glucose levels, i.e. the rateof absorption of glucose in the blood.

Obesity is the main reason for performing bariatric surgery. Before thestart of the operation it may be needed to induce weight loss and aftera successful operation it may be necessary to induce satiety incombination with the provision of sufficient essential vitamins andminerals. In a preferred embodiment, the composition according to theinvention can be used for the treatment of weight loss-related symptomsin bariatric surgery patients.

Example 1

The Example describes a preferred nutritional composition in the form ofa powder for the treatment of bariatric surgery patients

Nutrient Content Protein Whey Based Low Lactose Protein ¹ 30 gCarbohydrate Maltodextrin/Modified Starch ² 29 g Prebiotic Synergy 1 ³10 g Fat Safflower Oil/Canola/Cocunut Oil 5 g Blend (1:1:0.1) Calories320 Kcal Iron 25 mg Vitamin B12 350 mcg Calcium 1500 mg Vitamin D 25 mcgPhosphorus 1070 mg Vitamin E 40 mgTE Vitamin C 180 mg Other vitamins, To90.6 g minerals and trace elements to meet 150% RDA and Flavouring ¹Lactose content ca 0.25% ² MD:MS ca 3.3:1 ³ Ex Orafti (ca 50% shortchain oligofructose and 50% long chain inulin)

As indicated the total weight of the composition is 90.6 g. Thisrepresents the amount to be administered per day to the patient. Theproduct would be packaged as two sachets each containing 45.3 g of theformulation. Each sachet would be mixed with water to give a liquidproduct having a volume of 125-135 ml. The patient would receive two ofthese liquid products per day.

REFERENCES

-   1. Xanthakos S A, Inge T H. Nutritional consequences of bariatric    surgery. Curr Opin Clin Nutr Metab Care 2006; 9:489-96.-   2. Malinowski S S. Nutritional and metabolic complications of    bariatric surgery. Am J Med Sci 2006; 331:219-25.-   3. Parkes E. Nutritional management of patients after bariatric    surgery. Am J Med Sci 2006; 331:207-13.-   4. Jackson K G, Taylor G R, Clohessy A M, Williams C M. The effect    of the daily intake of inulin on fasting lipid, insulin and glucose    concentrations in middle-aged men and women. Br J Nutr 1999;    82:23-30.-   5. Brighenti F, Casiraghi M C, Canzi E, Ferrari A. Effect of    consumption of a ready-to-eat breakfast cereal containing inulin on    the intestinal milieu and blood lipids in healthy male volunteers.    Eur J Clin Nutr 1999; 53:726-33.-   6. Langlands S J, Hopkins M J, Coleman N, Cummings J H. Prebiotic    carbohydrates modify the mucosa associated microflora of the human    large bowel. Gut 2004; 53:1610-6.-   7. Davidson M H, Maki K C. Effects of dietary inulin on serum    lipids. J Nutr 1999; 129:1474 S-7S.-   8. Pedersen A, Sandstrom B, Van Amelsvoort J M. The effect of    ingestion of inulin on blood lipids and gastrointestinal symptoms in    healthy females. Br J Nutr 1997; 78:215-22.-   9. Cook J D, Monsen E R. Vitamin C, the common cold, and iron    absorption. Am J Clin Nutr 1977; 30:235-41.

1. Composition comprising 20-60 wt % protein source, 15-55 wt % lowglycemic carbohydrate, 10-20 wt % soluble dietary fibres, less than 10wt % fat and micronutrients, wherein the micronutrients comprise 0.75-3wt % calcium, 0.5-1.8 wt % phosphorus, 12.5-100 mg/100 g of iron, 10-100mcg/100 g vitamin D, and 175-560 mcg/100 g vitamin B12 the wt % beingbased on the dry weight of the total composition.
 2. Compositionaccording to claim 1 comprising 0.5-1.5 wt % phosphorus.
 3. Compositionaccording to claim 1 comprising 175-560 mcg/100 g vitamin B12. 4.Composition according to claim 1 comprising 0.5-1.5 wt % phosphorus and175-500 mcg/100 g vitamin B12.
 5. Composition according to claim 1wherein the carbohydrate comprises at least one selected from the grouplow glycemic carbohydrates consisting of fructose, galactose,isomaltulose and slow digestible starch.
 6. Composition according toclaim 1 wherein the protein source is a low lactose or lactose free,protein source.
 7. Composition according to claim 6 comprising 20-60 wt% of the low lactose or lactose free protein source.
 8. Compositionaccording to claim 7 comprising 20-40 wt % of the low lactose or lactosefree protein source.
 9. Composition according to claim 1 wherein thesoluble dietary fibres comprise at least inulin and/orfructooligosaccharide.
 10. Composition according to claim 1 wherein thefat comprises a blend of hybrid safflower oil, canola oil and coconutoil.
 11. Composition according to claim 1 wherein the amount of vitaminD is 10-30 mcg/100 g dry weight of the composition.
 12. Compositionaccording to claim 11 wherein the amount of vitamin D is 10-20 mcg/100 gdry weight of the composition.
 13. Composition according to claim 1wherein vitamin D consists essentially of vitamin D3.
 14. Compositionaccording to claim 1 containing from 12.5 to 75 mg/100 g of iron. 15.Composition according to claim 1 wherein the iron is fat coated. 16.Composition according to claim 1 containing 250 to 500 mcg/100 g ofvitamin B12.
 17. Composition according to claim 1 containing 1.2-3 wt %calcium.
 18. Composition according to claim 1 wherein the ratio ofcalcium: phosphorus (Ca:P) is 1.4.
 19. A composition according to claim1 for use in: a. inducing liver size reduction pre-operatively inbariatric surgery patients, b. prevention and/or treatment of bonecalcium depletion and osteopenia in bariatric surgery patients, c.prevention and treatment of post-operative nutritional deficiencies inbariatric surgery patients, d. improve GI function or bowel health inbariatric surgery patients, e. induction of weight loss pre and postbariatric surgery, f. inducing satiety in bariatric surgery patients, org. preventing dumping syndrome in bariatric surgery patients h.maintaining glycaemic control in obese gastric bypass surgery patients.20. A composition according to claim 1 for use in pre and post operativetreatment of bariatric surgery patients.
 21. Composition according toclaim 20 wherein the surgery is selected from Roux-en-Y gastric bypass(RYGBP), adjustable gastric band (AGB), vertical banded gastroplasty(VBG) and Bilio-pancreatic diversion (BPD).
 22. Use of a compositioncomprising 20-60 wt % protein source, 15-55 wt % carbohydrate, 10-20 wt% soluble dietary fibres, less than 10 wt % fat and micronutrients,wherein the micronutrients comprise 0.75-3 wt % calcium, 0.5-1.8 wt %phosphorus, 12.5-100 mg/100 g of iron, 10-100 mcg/100 g vitamin D, and175-560 mcg/100 g vitamin B12 the wt % being based on the dry weight ofthe total composition for the preparation of a medical nutrition for thetreatment of obese patients after gastric bypass surgery.
 23. Use ofcomposition comprising 20-60 wt % protein source, 15-55 wt %carbohydrate, 10-20 wt % soluble dietary fibres, less than 10 wt % fatand micronutrients, wherein the micronutrients comprise 0.75-3 wt %calcium, 0.5-1.8 wt % phosphorus, 12.5-100 mg/100 g of iron, 10-100mcg/100 g vitamin D, and 175-560 mcg/100 g vitamin B12 the wt % beingbased on the dry weight of the total composition for the preparation ofa medical nutrition for the treatment of nutritional deficiencies inobese patients pre and post gastric bypass surgery.